MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7493932430

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.The returned product consisted of a comet pressure guidewire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.The proximal end of the shaft measured approximately 162.5cm.The distal end measured 22.5cm, for a total length of 185cm.The total length of a complete comet wire is 185cm.The separated ends of the device are consistent with torsional bending.There were multiple bends throughout the wire length.The distal tip showed a bend.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.The sensor port showed no evidence of blood.Functional testing of the device could not be completed due to the separation of the shaft.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018.It was reported that tip damage occurred.The target lesion was an angio-phase lesion located in the 85% moderately tortuous and severely calcified mid left anterior artery.A comet pressure guidewire was used to see fractional flow reserve while baseline value was not measured.It was noted the tip of the comet pressure guidewire was damaged.After the disease was diagnosed with intravascular ultrasound, the percutaneous coronary intervention procedure was performed.The procedure was completed with a different device.There were not patient complications and the patient's condition was stable.However, returned device analysis revealed tip separation.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7695667
• MDR Text Key: 114330249
• Report Number: 2134265-2018-06246
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: H7493932430
• Device Lot Number: 21350144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR